510(k) K200050 ยท IWB System, Radiation Therapy, Radionuclide
Akesis Galaxy RTx
| Applicant | Akesis, Inc., Concord CA, US |
| Decision | Substantially Equivalent, Feb 4, 2020 |
| Received | Jan 10, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200050
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.